Safety and feasibility of the OmniPod hybrid closed-loop system in adult, adolescent, and pediatric patients with type 1 diabetes using a personalized model predictive control algorithm. 2011;5(6):1509-1518. Human regular U-500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study. Diabetes Obes Metab. The intended design of the technology is to leverage glucose values from a CGM to … 2018;20(4):257-262. The study demonstrated that the investigational Omnipod Horizon System performed well and was safe for up to four days of use in children as young as two years old with type 1 diabetes. This will be followed by a 94-day (13-week) hybrid closed-loop phase, conducted in an outpatient setting where subjects, or their caregivers, will manage their diabetes at home using the Omnipod Horizon™ Automated Glucose Control System. 2008;31(2):238-239. Polonsky WH, Hessler D, Layne JE, Zisser H. Impact of the Omnipod® Insulin Management System on Quality of Life: A Survey of Current Users. J Diabetes Sci Technol. Currently participating or plans to participate in another clinical study using an investigational drug or device other than Omnipod Horizon™. 2020. For now, only select Android phones offer a compatible app, … Zaharieva DP, Turksoy K, McGaugh SM, Pooni R, Vienneau T, Ly T, Riddell MC. J Diabetes Sci Technol. It works with a mobile phone or personal diabetes manager. "Our new Omnipod Horizon System is designed to deliver not only improved clinical outcomes, but the greatly desired improvement in quality of life for those living with insulin-dependent diabetes," said Patrick Sullivan, President and Chief Executive Officer. COVID-19: view a video response from our CEO, Submit your research proposal through our Investigator Initiated Trial Portal, https://www.liebertpub.com/doi/10.1089/dia.2018.0364, https://care.diabetesjournals.org/content/42/5/824, https://journals.sagepub.com/doi/full/10.1177/1932296818804802, https://journals.sagepub.com/doi/full/10.1177/1932296817735341, https://journals.sagepub.com/doi/full/10.1177/1932296816638674, https://www.liebertpub.com/doi/10.1089/dia.2016.0239?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting and an optional 6-month extension phase. The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation. SAN FRANCISCO – Insulet Corp. aims to get an FDA approval this year and launch its first interoperable device, the cord-free, wearable insulin device Omnipod Horizon. This will be followed by a 5-day/4-night, or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting. J Diabetes Sci Technol. List of studies authored or sponsored by Insulet Corporation. The … Bill pay function available for Podders™ with valid credit card information on file. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The Endocrine Society is the world’s first and largest organization dedicated to research on hormones and the clinical practice of endocrinology. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 6 months. Layne JE, Huyett LM, Ly TT. Launch of Omnipod Horizon is expected in the first half of 2021, a delay from original plans to launch by the end of this year. Zisser H, Breton M, Dassau E, Markova K, Bevier W, Seborg D, Kovatchev B. Diabetes Care. Masking: None (Open Label) Primary Purpose: Treatment: Official Title: Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes: Actual Study Start Date : December 30, 2019: Actual Primary Completion Date : After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 6 months. Insulet said it plans to pause a pivotal clinical study of its upcoming wearable insulin pump due to an anomaly in the device’s software. J Diabetes Sci Technol. Diagnosis is based on investigator's clinical judgment, Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities, Investigator has confidence that the subject and/or parent/guardian/caregiver can successfully operate all study devices and is capable of adhering to the protocol, Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study, Willing to wear the system continuously throughout the study, Willing to participate in challenges for 2 consecutive days, consisting of a minimum of 3 hours of activity per day and dietary challenge by reducing the number of carbohydrates entered for a given meal by 50%, Subject and/or parent/guardian must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase, Subject and/or parent/guardian is able to read and speak English fluently. Omnipod, the Omnipod logo, DASH, the DASH logo, HORIZON, the HORIZON Logo, Omnipod DISPLAY, Omnipod VIEW, Omnipod DEMO, Podder, Toby the Turtle, PodderCentral, the PodderCentral logo, and PodderTalk are trademarks or registered trademarks of Insulet Corporation. With several clinical trials on hold due to the COVID-19 pandemic, we’re bringing you a roundup of the latest updates on future continuous glucose monitors ().Understandably, the FDA also announced a few months ago that it would focus its efforts on devices related to COVID-19. Long-term Study of Tubeless Insulin Pump Therapy Compared to Multiple Daily Injections in Youth with Type 1 Diabetes: Data from the German/Austrian DPV-Registry. The objective for the study was to assess the safety and efficacy of the Omnipod Horizon™ Automated Glucose Control System. Layne JE, Parkin CG, Zisser H. Efficacy of a Tubeless Patch Pump in Patients With Type 2 Diabetes Previously Treated With Multiple Daily Injections. Glooko is a trademark of Glooko, Inc. and used with permission. 2017;11(1):178-179. Subjects, or their caregivers, will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system (CGM) and remain on current multiple daily injections (MDI) or pump therapy. In a major splash at the 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Madrid, Spain, Insulet unveiled partnerships with continuous glucose monitor companies Abbott and Dexcom.Insulet announced plans to integrate … J Diabetes Sci Technol. A unique feature of the device is that it uses custom-built glucose control, modifiable based on the time of day; it can also prevent the patient from experiencing a hypoglycemia episode. Insulet to pause Omnipod Horizon … Diabetes Care. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting, and an optional 6-month extension phase. Pivotal Omnipod Horizon™ Automated Glucose Control System 1 (on-going trial) Patient with Type 1 diabetes will undergo a 14-day outpatient, standard therapy phase during which sensor and … Why Should I Register and Submit Results? 2019;21(6):313-321. Expanding upon the current Omnipod DASH Insulin Management System, Insulet has developed and is currently in clinical trials for its Omnipod Horizon™ AID System. We partner with researchers and centers of excellence worldwide to conduct studies in patients with diabetes of various ages using Omnipod DASH® Insulin Management System or Omnipod® Insulin Management System and other products in development. single-arm, multi-center, prospective clinical study: Masking: None (Open Label) Primary Purpose: Treatment: Official Title: Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Children With Type 1 Diabetes Aged 2.0-5.9 Years: Preschool Cohort: Actual Study Start Date : September 8, 2020 “Our investment in mobile technology and interoperability ensures … 2019;13(1):20-26. Ascensia and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care. Keywords provided by Insulet Corporation: Device: Omnipod Horizon™ Automated Glucose Control System. All rights reserved. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide), Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism, Currently participating or plans to participate in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System during this study period, Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment. Pillalamarri SS, Huyett LM, Abdel-Malek A. Diabetes Technol Ther. 2016 Layne JE, Parkin CG, Zisser H. Efficacy of the Omnipod Insulin Management System on Glycemic Control in Patients With Type 1 Diabetes Previously Treated With Multiple Daily Injections or Continuous Subcutaneous Insulin Infusion. In Silico Modeling of Minimal Effective Insulin Doses Using the UVA/PADOVA Type 1 Diabetes Simulator. Choosing to participate in a study is an important personal decision. 2019;21(5):265-272. Omnipod ® Horizon ™ System Significantly Improves Glycemic Control in Patients with Type 1 Diabetes. Talk with your doctor and family members or friends about deciding to join a study. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Learn how Stanford Health Care brings together leading-edge technology, innovative research, and world-renowned experts to meet your unique needs. Novel methodology to determine the accuracy of the OmniPod insulin pump: a key component of the artificial pancreas system. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Diabetes Technol Ther. OmniPod Artificial Pancreas System Clinical Trial By Lisa Foster-McNulty, MSN, RN, CDE If you are interested in participating in a study involving the use of the OmniPod Horizon Hybrid Closed Loop System, you might want to check out ClinicalTrials.gov to see if you qualify. Forlenza GP, Buckingham BA, Christiansen MP, Wadwa RP, Peyser TA, Lee JB, O'Connor J, Dassau E, Huyett LM, Layne JE, Ly TT. estimated GFR < 45) or currently on hemodialysis, Has taken oral or injectable steroids within the past 8-weeks or plans to take oral or injectable steroids during the course of the study, Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement, Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study, Use of non-insulin anti-diabetic medication other than metformin (e.g. The experience highlights the benefits of our significant investment in mobile and cloud technology, which enable our engineers to monitor enormous amounts of information in real-time from the Omnipod Horizon clinical trials. Buckingham BA, Christiansen MP, Forlenza GP, Wadwa RP, Peyser TA, Lee JB, O'Connor J, Dassau E, Huyett LM, Layne JE, Ly TT. Diabetes Technol Ther. Please see the following information from the ClinicalTrials.gov website to learn more about clinical trials in progress. A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk, History of severe hypoglycemia in the past 6 months, History of DKA in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis, Diagnosed with hemophilia or any other bleeding disorders, Plans to receive blood transfusion over the course of the study, Clinical evidence of acute or chronic kidney disease (e.g. 2016;18(10):664-670. Jul 9. After the conclusion of the three presentations on Medtronic’s 780G system, Dr. Bruce Buckingham from Stanford University presented the pre-pivotal trial results from Insulet’s Omnipod 5, powered by Horizon. A 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. 2016;10(5):1130-5. 2018;12(6):1132-1142. This is a single-arm, multi-center, prospective clinical study. This information allowed us to quickly identify, investigate, and decide to correct the issue. Information provided by (Responsible Party): Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. What the trial is testing: The Omnipod Horizon is an automated insulin delivery system that uses continuous glucose monitor readings to automatically adjust basal insulin delivery. Subjects may be recruited from the Omnipod Horizon Pivotal Study (G190270) prior to their recommencement of … Get the latest research information from NIH: You have reached the maximum number of saved studies (100). The Omnipod® 5 Automated Insulin Delivery System1 is a hybrid, closed-loop platform in development. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting, and an optional 6-month extension phase. Diabetes Technol Ther. Insulet’s hybrid closed loop — Omnipod Horizon — is gearing up to enter Phase 3 clinical trials later this year and aiming for a public release in the second half of 2020. By Albert Cai. Zisser HC, Bevier W, Dassau E, Jovanovic L. Siphon effects on continuous subcutaneous insulin infusion pump delivery performance. COVID-19 is an emerging, rapidly evolving situation. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Device Product Not Approved or Cleared by U.S. FDA: Incidence rate of severe hypoglycemia (events per person months) [ Time Frame: Phase 2 hybrid closed-loop (94 days) ], Incidence rate of diabetic ketoacidosis (DKA) (events per person months) [ Time Frame: Phase 2 hybrid closed-loop (94 days) ], Glycated hemoglobin (A1C) [ Time Frame: Phase 2 hybrid closed-loop (94 days) compared to baseline ], Time in range 70-180 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days) ], Glycated hemoglobin (A1C) [ Time Frame: Hybrid closed-loop: 3 months (94 days), 6 months (180 days), and 9 months (270 days) compared to baseline ], Percent of time in range 70-180 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percent of time in range 70-140 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percent of time > 180 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percent of time ≥ 250 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percent of time ≥ 300 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percent of time < 70 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percent of time < 54 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Mean glucose [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Standard deviation [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Coefficient of variation [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percentage of time in hybrid closed-loop as proportion of overall device usage time [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 (270 days) ], Glucose management indicator (GMI) based on overall mean glucose [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Total daily insulin (TDI) (units) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Total daily insulin (TDI) (units/kg) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Total daily basal insulin (units) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Total daily basal insulin (units/kg) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Total daily bolus insulin (units) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Total daily bolus insulin (units/kg) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Body Mass Index (BMI) (kg/m2) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to baseline ], Diagnosed with type 1 diabetes. 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